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	<title>Comments on: FDA May Loosen up Morning-After-Pill Restrictions</title>
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		<title>By: Gollum</title>
		<link>http://www.outsidethebeltway.com/archives/fda_may_loosen_up_morning-after-pill_restrictions/comment-page-1/#comment-92339</link>
		<dc:creator>Gollum</dc:creator>
		<pubDate>Mon, 31 Jul 2006 20:40:05 +0000</pubDate>
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		<description>Of course it&#039;s political maneuvering.  They did the &lt;a href=&quot;http://www.bloomberg.com/apps/news?pid=20601087&amp;sid=aFxthcj5Ui_o&amp;refer=home&quot; rel=&quot;nofollow&quot;&gt;same thing&lt;/a&gt; last year.

&lt;blockquote&gt;Last year, Clinton and Murray permitted confirmation of former FDA Commissioner Lester Crawford when the agency agreed to act on the Plan B application by September. The FDA in August delayed the decision indefinitely for more study. Murray and Clinton said they had been misled.&lt;/blockquote&gt;

And here&#039;s a little &lt;a href=&quot;http://www.nytimes.com/2006/07/31/giving/31cnd-pill.html?hp&amp;ex=1154404800&amp;en=3df0f0cc0e529b01&amp;ei=5094&amp;partner=homepage&quot; rel=&quot;nofollow&quot;&gt;background&lt;/a&gt;.

&lt;blockquote&gt;In December 2003, an F.D.A. advisory committee voted 23 to 4 to approve Barr&#039;s application with no age restrictions. Six months later, however, a top agency official rejected the application, citing concerns that the pill would be available to young teenagers.

. . .

While the F.D.A. has insisted that its decisions to reject or delay the Plan B application were the result of scientific or regulatory concerns, a Congressional investigation found last year that top agency officials decided at one point to reject the application before its staff&#039;s scientific review was even complete.&lt;/blockquote&gt;

and an interesting &lt;a href=&quot;http://www.forbes.com/home/feeds/ap/2006/07/28/ap2912862.html&quot; rel=&quot;nofollow&quot;&gt;twist from Forbes&lt;/a&gt; last week:

&lt;blockquote&gt;A group demanding easier access to the emergency contraceptive Plan B said Friday it seeks to subpoena White House e-mails and other documents as part of its lawsuit against the Food and Drug Administration.

The Center for Reproductive Rights is seeking permission to request any e-mails, letters and records of conversations exchanged by the White House and the FDA to determine whether the administration weighed in with &quot;instructions or directions&quot; to regulators on how to proceed with a drug maker&#039;s request to allow over-the-counter sales of the pills.&lt;/blockquote&gt;</description>
		<content:encoded><![CDATA[<p>Of course it's political maneuvering.  They did the <a href="http://www.bloomberg.com/apps/news?pid=20601087&amp;sid=aFxthcj5Ui_o&amp;refer=home" rel="nofollow">same thing</a> last year.</p>
<blockquote><p>Last year, Clinton and Murray permitted confirmation of former FDA Commissioner Lester Crawford when the agency agreed to act on the Plan B application by September. The FDA in August delayed the decision indefinitely for more study. Murray and Clinton said they had been misled.</p></blockquote>
<p>And here's a little <a href="http://www.nytimes.com/2006/07/31/giving/31cnd-pill.html?hp&amp;ex=1154404800&amp;en=3df0f0cc0e529b01&amp;ei=5094&amp;partner=homepage" rel="nofollow">background</a>.</p>
<blockquote><p>In December 2003, an F.D.A. advisory committee voted 23 to 4 to approve Barr's application with no age restrictions. Six months later, however, a top agency official rejected the application, citing concerns that the pill would be available to young teenagers.</p>
<p>. . .</p>
<p>While the F.D.A. has insisted that its decisions to reject or delay the Plan B application were the result of scientific or regulatory concerns, a Congressional investigation found last year that top agency officials decided at one point to reject the application before its staff's scientific review was even complete.</p></blockquote>
<p>and an interesting <a href="http://www.forbes.com/home/feeds/ap/2006/07/28/ap2912862.html" rel="nofollow">twist from Forbes</a> last week:</p>
<blockquote><p>A group demanding easier access to the emergency contraceptive Plan B said Friday it seeks to subpoena White House e-mails and other documents as part of its lawsuit against the Food and Drug Administration.</p>
<p>The Center for Reproductive Rights is seeking permission to request any e-mails, letters and records of conversations exchanged by the White House and the FDA to determine whether the administration weighed in with "instructions or directions" to regulators on how to proceed with a drug maker's request to allow over-the-counter sales of the pills.</p></blockquote>
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